Senior Quality Consultant

Medtech Services

Confirmed live in the last 24 hours

Locations

Philadelphia, PA, USA

Experience Level

Entry

Junior

Mid

Senior

Expert

Desired Skills

Management

Sales

Requirements

8 + years of relevant work experience within Life Sciences, Healthcare, or other regulated industries (ex. Consumer Goods, Chemical, Cosmetics)
Experience implementing, designing solutions, and supporting software applications
Self-starter and motivated individual with the proven ability to work independently in a dynamic environment
Intermediate knowledge of Quality related processes (e.g. CAPA, Complaints, Non-Conformance, Product Surveillance, Change Management)
Understanding of compliance and computer systems validation requirements
Proven ability to manage diverse customers and /or stakeholders and ability to communicate at multiple levels of the organization
Ability to quickly understand customer requirements and create corresponding solution designs
Knowledge of SaaS/Cloud software solutions
Bachelor's degree or equivalent work experience required

Responsibilities

Lead Veeva Vault Quality implementations and handle project management responsibilities, such as resource planning, project risk management, leading cross-functional teams, and budget tracking & forecasting of the engagement
Conduct Vault Design Review and Configuration workshops with MedTech stakeholders from Business and IT: gather requirements, design & prototype, configure and support the validation of the delivered Quality processes
Work closely with customers' business and IT stakeholders and develop scalable solutions that meet Quality regulatory compliance and customer requirements
Mentor project team members and junior consultants
Continue to develop industry knowledge and enhancements the delivery model to meet the changing business needs of Veeva and our customers
Provide insight and recommendations to improve our technology and work closely with our Product team to ensure the best solutions for our customers

Desired Qualifications

Work experience in Medical Devices and/or Diagnostics space
Computer Science, Life Science, or related degree preferred
Strong knowledge of MedTech industry standards and regulatory requirements (e.g.: FDA QSR, ISO 13485, 21 CFR Part 11, 21 CFR 820, 210, GAMP)
Direct experience with regulated systems or data-driven applications such as Veeva Vault solutions, NextDocs, Documentum, FirstDoc/FirstPoint, Trackwise, Medidata, Liquent Insight
Experience with PLM and LIMs systems such as Arena, TeamCenter, Propel, Agilent, Labworks
SaaS/Cloud delivery experience
Experience in Services Delivery Management or Pre-Sales presentations and demonstrations

Veeva [NYSE: VEEV] is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, our customers range from the world’s largest pharmaceutical companies to emerging biotechs. Veeva’s software helps our customers bring medicines and therapies to patients faster.

We are the first public company to become a Public Benefit Corporation. As a PBC, we are committed to making the industries we serve more productive, and we are committed to creating high-quality employment opportunities.

Veeva is a Work Anywhere company which means that you can choose to work in the environment that works best for you - on any given day. Whether you choose to work remotely from home or work in an office - it’s up to you.

The Role

Are you driven and self-motivated? Are you passionate about bringing purpose-built technologies that enable greater compliance and process efficiencies to MedTech Companies? Are you looking for a collaborative work environment where you are encouraged to contribute and share your thoughts and ideas?

Veeva is looking for experienced professionals to implement Veeva Vault Quality solutions for our Medical Device and Diagnostic customers. The ideal candidate will utilize their industry experience to transform the way our customers collect, maintain, and Quality related processes and documentation. They will also contribute ideas and work with other Veeva team members to innovate and refine our internal processes, share feedback and work with our product team, and enhance our delivery model to meet the ever-changing needs of the MedTech industry.

This is a remote, full-time permanent role with Veeva. There is no work location requirement. This is a customer-facing role with a requirement for travel of up to 40%. Veeva Systems does not anticipate providing sponsorship for employment visa status for this employment position.

What You’ll Do

Lead Veeva Vault Quality implementations and handle project management responsibilities, such as resource planning, project risk management, leading cross-functional teams, and budget tracking & forecasting of the engagement
Conduct Vault Design Review and Configuration workshops with MedTech stakeholders from Business and IT: gather requirements, design & prototype, configure and support the validation of the delivered Quality processes
Work closely with customers’ business and IT stakeholders and develop scalable solutions that meet Quality regulatory compliance and customer requirements
Mentor project team members and junior consultants
Continue to develop industry knowledge and enhancements the delivery model to meet the changing business needs of Veeva and our customers
Provide insight and recommendations to improve our technology and work closely with our Product team to ensure the best solutions for our customers

Requirements

8 + years of relevant work experience within Life Sciences, Healthcare, or other regulated industries (ex. Consumer Goods, Chemical, Cosmetics)
Experience implementing, designing solutions, and supporting software applications
Self-starter and motivated individual with the proven ability to work independently in a dynamic environment
Intermediate knowledge of Quality related processes (e.g. CAPA, Complaints, Non-Conformance, Product Surveillance, Change Management)
Understanding of compliance and computer systems validation requirements
Proven ability to manage diverse customers and /or stakeholders and ability to communicate at multiple levels of the organization
Ability to quickly understand customer requirements and create corresponding solution designs
Knowledge of SaaS/Cloud software solutions
Bachelor’s degree or equivalent work experience required

Nice to Have

Work experience in Medical Devices and/or Diagnostics space
Computer Science, Life Science, or related degree preferred.
Strong knowledge of MedTech industry standards and regulatory requirements (e.g.: FDA QSR, ISO 13485, 21 CFR Part 11, 21 CFR 820, 210, GAMP)
Direct experience with regulated systems or data-driven applications such as Veeva Vault solutions, NextDocs, Documentum, FirstDoc/FirstPoint, Trackwise, Medidata, Liquent Insight
Experience with PLM and LIMs systems such as Arena, TeamCenter, Propel, Agilent, Labworks
SaaS/Cloud delivery experience
Experience in Services Delivery Management or Pre-Sales presentations and demonstrations

Perks & Benefits

Allocations for continuous learning & development
Health & wellness programs
Flexible PTO

#LI-Remote

#BI-Remote

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [email protected]

1,001-5,000 employees

Website

Cloud computing services for pharmaceutical companies.

Company Overview

Veep's mission is to help R&D, quality, and regulatory teams eliminate inefficiencies and bring high-quality, safe, sustainable products to market without compromising quality. The company builds cloud-based tools for pharmaceutical research.

Benefits

Parental leave
PTO
Free food
Health, dental, & vision insurance
Gym membership reimbursement

Company Core Values

Do the Right Thing
Customer Success
Employee Success
Speed